First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)

Universiteit Antwerpen

Status: Completed

Conditions: Cervical Cancer

Treatments: Device: Qvintip; Device: Colli-Pee

Study type: Observational

Funder types: Other

Identifiers

NCT03542513

B300201732818

Details and patient eligibility

About

The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).

Full description

In total 100 women, diagnosed with CIN2/3 and scheduled for LLETZ (Large Loop Excision of the Transformation Zone), will be included in this trial. These women are asked to collect two FV urine samples with the Colli-Pee device (Novosanis, Wijnegem, Belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. In addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. Qvintip devices are used for vaginal self-sampling.

During follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the UZA anatomic pathology unit to determine the patient's HPV status, cytology and histology. For the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Female (18 years and older)
• Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions
• Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy.
• Not participating in another clinical study where a drug or biological is administered.
• Able to understand the information brochure/what the study is about.